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| Name | Class |
|---|---|
| North-Western State Medical University named after I.I.Mechnikov | OTHER |
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The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.
Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.
The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.
The treatment regimen in this study will also include a basic antituberculosis therapy.
The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.
The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon | Experimental | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy |
|
| Interferon daily | Experimental | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy |
|
| Control | No Intervention | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-Gamma | Drug | received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Culture | Precentage of participants with negative sputum culture | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Hemoglobin Level | Level of hemoglobin (g/L) | Screening, Week 8 |
| Leucocytes Level | Number of leukocytes | Screening, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Shmelev, Doctor | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health | Saint Petersburg | Sankt-Peterburg | 195067 | Russia | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| CD3 | CD3 cells level in absolute numbers and percents | Screening, Week 4 |
| CD4 | CD4 cells level in absolute numbers and percents | Screening, Week 4 |
| CD8 | CD8 cells level in absolute numbers and percents | Screening, Week 4 |
| CD4/CD8 | Immunoregulatory index value | Screening, Week 4 |
| City Tuberculosis Hospital #2 of Saint-Petersburg |
| Saint Petersburg |
| Sankt-Peterburg |
| Russia |
| FG001 | Interferon Daily | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
| FG002 | Control | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Interferon | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
| BG001 | Interferon Daily | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
| BG002 | Control | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sputum Culture | Precentage of participants with negative sputum culture | Posted | Count of Participants | Participants | Week 4 |
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| Secondary | Average Hemoglobin Level | Level of hemoglobin (g/L) | Not Posted | Screening, Week 8 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Leucocytes Level | Number of leukocytes | Not Posted | Screening, Week 4 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | CD3 | CD3 cells level in absolute numbers and percents | Not Posted | Screening, Week 4 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | CD4 | CD4 cells level in absolute numbers and percents | Not Posted | Screening, Week 4 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | CD8 | CD8 cells level in absolute numbers and percents | Not Posted | Screening, Week 4 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | CD4/CD8 | Immunoregulatory index value | Not Posted | Screening, Week 4 | Participants |
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interferon | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Interferon Daily | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Control | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. Sc., Prof. Tamara Sologub | Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health, Saint-Petersburg, Russia, 195067 | +78125439609 | mechnik@mail.ru |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014397 | Tuberculosis, Pulmonary |
| D000163 | Acquired Immunodeficiency Syndrome |
| D016180 | Lentivirus Infections |
| D012327 | RNA Virus Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D012192 | Retroviridae Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| 18-50 y.o. |
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| over 50 y.o. |
|
| Male |
|